CLASS II Drug recall · Reported 4 Jan 2023 · FDA Enforcement Report
Glycopyrrolate Tablets, USP, 1 mg Unit Dose recalled by AVKARE
Avkare is recalling Glycopyrrolate Tablets, USP, 1 mg Unit Dose, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0091-2023
- FDA event ID
- 91390
- Recalling firm
- Avkare, Pulaski, TN
- Brand
- Glycopyrrolate
- Manufacturer
- AvPAK
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 22 Dec 2022
- FDA classified
- 28 Dec 2022
- Reported
- 4 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Dec 2022 | Recall initiated by company | |
| 28 Dec 2022 | Classified by FDA | +6 days |
| 4 Jan 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Which lots are affected?
Lot#: 43313, 43342, Exp 12/2023
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Glycopyrrolate recalls
All 43| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Glycopyrrolate Oral Solution, 1 mg recalled by Novadoz PharmaceuticalsGlycopyrrolate | Novadoz Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | glycopyrrolate 1 mg/ (0.2 mg/mL), For Anesthesia Use, Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |